Health Technology Assessment - HTA · 2017-06-16 · Health Technology Assessment - HTA Washington...

Upper Endoscopy – Final Key Questions 1/11/2012

Health Technology Assessment - HTA

Washington State Health Care Authority, HTA Program

FINAL Key Questions and Background Upper Endoscopy for gastroesophageal reflux disease (GERD) and upper

gastrointestinal (GI) symptoms

Introduction Upper endoscopy for gastroesophageal reflux disease (GERD) was selected for review by the HTA program. Acid reflux is a condition where the acidic juices (digestive acids) regurgitate or reflux up into the esophagus. GERD is a more serious form of acid reflux. Occasional acid reflux is a common condition and does not necessarily mean a person has GERD. GERD can lead to more serious health problems due to the effect of digestive acid on the lining of the esophagus. Causes of GERD are varied, but may include anatomical abnormalities, obesity, pregnancy, and smoking. GERD may occur in children and adults. Persistent acid reflux may indicate GERD. Upper endoscopy is a diagnostic procedure. Upper endoscopy involves the insertion of a thin flexible tube down a patient’s throat and esophagus. The endoscope has a light and camera attached allowing a doctor to visually inspect the esophagus for abnormalities and to take small pieces of tissue (biopsy) if needed. Policy Context Upper GI symptoms, acid reflux and GERD are very common. Upper endoscopy is an invasive diagnostic procedure that may be indicated for persons with upper GI symptoms and/or a diagnosis of GERD. State agencies concerns: safety- Low, efficacy- Medium-High, cost- Medium-High.

Population: Adults with an initial presenting complaint of upper gastrointestinal symptoms

and/or GERD Intervention: Upper gastrointestinal endoscopy Comparator: Medical management without endoscopy – including screening questionnaires,

noninvasive H. pylori testing, empiric acid-suppression therapy Outcomes: Clinical symptom resolution (e.g. as measured by symptom scoring tools),

health care resource utilization, development of serious gastrointestinal pathology (e.g. malignancy, Barrett’s esophagus, esophageal stricture), quality of life indicators

Upper Endoscopy – Final Key Questions 1/11/2012

Health Technology Assessment - HTA

Key Questions KQ1: What is the evidence of effectiveness for early treatment strategies that include upper

endoscopy compared with empiric medical management? KQ2: Are there clinical signs and symptoms useful to identify patients for whom early

endoscopy is effective to improve health outcomes and/or disease management? KQ3: For what diagnoses and within what time frames, is repeat endoscopy indicated versus

other tests or no follow-up tests for surveillance of disease progression and/or treatment response? Does repeat endoscopy change treatment and outcome?

KQ4: What are the potential harms of performing upper endoscopy in the diagnostic or treatment planning workup of adults with upper GI symptoms? What is the incidence of these harms? Include consideration of progression of treatment in unnecessary or inappropriate ways.

KQ5: What is the evidence that upper endoscopy has differential efficacy or safety issues in sub populations? Including consideration of:

a. Gender b. Age c. Psychological or psychosocial co-morbidities d. Other patient characteristics or evidence based patient selection criteria,

especially comorbidities of diabetes, high BMI, and chronic ingestion of alcohol

e. Provider type, setting or other provider characteristics f. Payer / beneficiary type: including worker’s compensation, Medicaid, state

employees? KQ6: What is the evidence of cost and cost-effectiveness of endoscopy compared to other

treatment strategies when used in diagnostic or treatment planning workups of adults with upper GI symptoms?

Public comment and Response HTA received 1 public comment. The comment was forwarded to the technology assessment center for consideration and was reviewed by HTA program staff. The commenter recommended eliminating key question #1 and #2; recommended changing key question #3 from “…Does repeat endoscopy change treatment and outcome?” to “…Does endoscopy (initial or repeat) change treatment and outcome?”; and for key question 5, recommended adding under (d) individuals known to ingest alcohol chronically. Response: No changes to key questions 1, 2 and 3. Added “and chronic ingestion of alcohol” to KQ5 sub bullet (d).

For additional information on key questions and public comments

http://www.hta.hca.wa.gov/process_key_questions.html

Upper Endoscopy for GERD and GI Symptoms

Clinical Expert

Drew Blackham Schembre, MD

Swedish Medical Center

Chief and co-founder, Swedish Gastroenterology/Swedish Center for Digestive Health

2446 1st Ave N

Seattle, WA 98109

Curriculum Vitae

Drew Blackham Schembre, MD September 15, 2011

2446 1st Ave N.

Seattle, WA 98109

Phone: 206-341-0931

Fax: 206-223-6379

Mobile: 206-612-2391

Vital Statistics: DOB: September 16, 1961

Citizenship: United States

New York License # 206730

Utah License # 89-181661-1205

Washington State License # MD0006475

Positions:

2010-Present Chief and co-founder, Swedish

Gastroenterology/Swedish Center for Digestive Health,

Swedish Medical Center, Seattle, Washington. Establish-

ing new, tertiary care/advanced GI group at leading medi-

cal center in Pacific Northwest.

2006-2010 Chief, Division of Gastroenterology,

Virginia Mason Medical Center, Seattle, Washington.

Medical Director of a 15 physician GI/6 mid-level/80 em-

ployee division within a 450+ physician multi-specialty

group and tertiary referral center

Deputy Chief of Medicine, Virginia

Mason Medical Center

Clinical Associate Professor of Medicine, University of

Washington

1998-2006 Staff Gastroenterologist, Virginia Mason

Medical Center, Seattle, Washington. Areas of special in-

terest: diagnostic and therapeutic endoscopic ultrasound,

photodynamic therapy, endotherapy for esophageal cancer,

emerging endoscopic techniques

Clinical Associate Professor of Medicine, University of

Washington

1997-1998 Clinical Instructor, Division of

Gastroenterology, Columbia College of Physicians and

Surgeons, New York

1995-1997 Co-director, Division of Gastroenterology,

Talbert Medical Group, Salt Lake City, Utah

1995 Mountain West Gastroenterology

Salt Lake City, Utah

Winters, 1993-95 Emergency Physician, Snowbird Medical Clinic

Snowbird Ski Resort, Alta, Utah

1991-1992 Internist, Salt Lake Community Health

Centers, Salt Lake City, Utah

Education

1997-1998 Third Tier Fellowship in Advanced Endoscopic

Techniques, Columbia-Presbyterian Medical Center, New

York, Charles Lightdale, director. Emphasis on endoscopic

ultrasound, photodynamic therapy and clinical research

1992-1994 Fellowship in Gastroenterology

University of Utah Health Sciences Center


1988-1991 Internship/Residency in Internal Medicine

University of Utah Health Sciences Center


1984-1988 University of Medicine and Dentistry of New

Jersey, New Jersey Medical School

Newark, New Jersey

1979-1983 Middlebury College, Bachelor of Arts, Cum Laude

Biology/Literature

Certifications: Board Certified, Gastroenterology, 1995, 2005

Board Certified, Internal Medicine, 1991, 2001

Awards: Charles Flood Award for Clinical Research, 1998

New Jersey Medical Society Essay Award, 1986

Societies: President, Pacific Northwest

Gastroenterology Society, 2007

American Society of Gastroenterologic Endoscopy

Chair, Special Interest Group: Endotherapy for Esophageal

Diseases, 2010

Fellow, 2008

Member Practice

Management Committee 2004-2007

Alternate, CPT

Representative 2006-2008

Member ad hoc subcommittee on endoscopic ultra-

sound 2001-2002

American Gastroenterological Association

American College of Gastroenterology

Fellow, 2008

American Medical Association

King County Medical Society

Reviewer: Gastrointestinal Endoscopy

American Journal of Gastroenterology

Digestive and Liver Disease

Journal of Clinical Gastroenterology

Journal of the Esophagus

Current Clinical Research/Patents:

1. New device development. Responsible for design of Cook Echotip ProCore EUS

biopsy needle, launched 2010, patent pending.

2. On-going development of a variety of devices to facilitate endoscopic procedures

and to improve endoscopic safety efficiency.

Presentations:

1. Update on Capsule and Deep Enteroscopy, Pacific Northwest Gastrointesinal

Society full day meeting, Seattle, WA 9/17/11

2. Tertiary Gastroenterology, Fairbanks AK, 7/19/11

3. Emil Jobb GI Conference, Swedish Medical Center, Seattle WA (Course

organizer and director), 4/15/11

4. Advanced Imaging Facilitates Mucosal Resection, ASGE Hands-On Course,

Advanced Endoscopic Techniques, Oak Brook, IL 6/5/10

5. Esophageal Stenting in 2010, BSCI-sponsored DDW symposium, New Orleans,

LA, 5/3/10

6. Small Bowel Enteroscopy: From Bench to Bedside, DDW 2010, New Orleans,

LA, 5/5/10

7. Advances in the use of removable esophageal stents, Internal Medicine Grand

Rounds, Madigan Army Base, Tacoma, WA, 4/7/10

8. Rendezvous Endoscopy for Obstructed Esophagus and Colon, Society of

Gastrointestinal Intervention, Seoul, Korea, 10/10/09

9. Advances in Tertiary Gastroenterology, Fifth Annual Current

Issues in Cancer Care: A Symposium for Primary Care Providers,

October 3, 2009, Campbell's Resort at Lake Chelan, WA.

10. Endotherapy for Early Esophageal Cancer, John Muir Cancer Center, Walnut

Creek, CA 9/17/09.

11. Deep Enteroscopy, Meet the Professor, DDW 2009, Chicago, IL. 5/26/09

12. Advanced Small Bowel Imaging Hands on Course, DDW 2009 Chicago, IL

5/23/09

13. Deep Entersoscopy: The long and winding road. GI Potpourri, Virginia Mason

Medical Center, Seattle, 3/14/09

14. Narrow-Band Imaging in the Esophagus and Colon. Vancouver, BC, 1/20/09

15. Endotherapy for Early Esophageal Neoplasia: Change we can believe in. Annual

Midwestern Oncology Conference, Nov. 4, 2008, Omaha NE

16. Narrow-Band Imaging in the Esophagus and Colon. Olympus University,

Anchorage AK, 7/9/08

17. Endotherapy versus Esophagectomy: Don’t throw the esophagus out with the

bathwater, Society for Surgery of the Alimentary Tract, Digestive Disease Week,

San Diego, CA, 5/20/08

18. Deep Enteroscopy, Meet the Professors, Digestive Disease Week, San Diego, CA,

5/19/08

19. Deep Enteroscopy Coding, An inconvenient truth. ASGE Deep Enteroscopy

Training Course, Chicago IL, 3/2008 and 11/2007

20. Double Balloon Enteroscopy and Competing Technologies, Symposium Co-

Chair, Digestive Disease Week, Washington, DC, 5/07

21. Small Bowel Enteroscopy, the ShapeLock experience, Digestive Disease Week,

Washington, DC, 5/07

22. Coding for Endoscopic Ultrasoud, EUS special interest group, Digestive Disease

Week, Washington, DC, 5/07

23. Photodynamic Therapy for Cholangiocarcinoma—the Virginia Mason

Experience, Congress of the International Photodynamic Therapy Association,

Shanghai, China, 3/29/07

24. Endotherapy versus Surgery for Barrett’s Esophagus with High-Grade Dysplasia,

Virginia Mason Medical Center, Grand Rounds, 11/3/06

25. The Evolution of Esophageal Stenting: From Sandelwood to Silicone, Portland,

OR, 6/06

26. Endotherapy versus Surgery for Barrett’s Esophagus with High-Grade Dysplasia,

Digestive Disease Week, Los Angeles, 5/06

27. Oncogel Injection for Unresectable Esophageal Cancer (video presentation),

World Congress of Gastroenterology, Montreal, Canada, 9/05

28. Photodynamic Therapy for Cholangiocarcinoma, MD Anderson

Pancreaticobiliary Conference, Hyanis, MA, 6/05

29. Comparison of endoscopic therapy versus esophagectomy for Barrett’s

30. esophagus with dysplasia or early cancer. Western States Thoracic Surgery

Society, Vancouver, BC, 6/05

31. Advances in gastrointestinal endoscopy: the fantastic voyage, GI NursingUpdate,

Virginia Mason Medical Center, 3/12/05

32. Double Balloon Enterosocpy, Univ. of Washington GI Grand Rounds, 3/05

33. Endoscopic therapies for esophageal cancer, Virginia Mason Medical

Center,Cancer Update, 2/05

34. Colon Cancer Update, Seattle Rotary, 1/05

35. Endoscopic ablative therapies for early esophageal and biliary malignancies,Salt

Lake Gut Club, Salt Lake City, Utah, 1/20/05

36. Endoscopic ablative therapies for early esophageal and biliary malignancies,

VMMC, 10/04

37. Endoscopic ablative therapies for early esophageal and biliary malignancies,

Bellingham, Washington, 10/04

38. Establishing Standards for Endoscopic Ultrasound, Frontiers in Endoscopy, Sante

Fe, New Mexico, 9/04

39. Potential and Pitfalls of EUS in Private Practice, Digestive Disease Week ASGE

endoscopic ultrasound special interest group, New Orleans, 5/18/04

40. Standard Work for Ulcerative Colitis, VMMC Grand Rounds, 4/23/04

41. Ablative therapy of esophageal and biliary neoplasms, Spokane, WA 4/04

42. Ultra-Jumbo biopsy forceps for Barrett’s esophagus, Univ. Washington GI Grand

Rounds, 3/04

43. Endoscopic therapy for early esophageal and biliary malignancies, Vancouver Gut

Club, Vancouver, BC 1/04

44. “Smart Endoscopes” Frontiers in Endoscopy, Santa Fe New Mexico, 9/03

45. Endoscopic therapy for early esophageal malignancies and dysplasia, Anchorage,

AK 3/03

46. Endoscopic therapy for early esophageal malignancies and dysplasia, Tacoma,

Washington, 3/03

47. Photodynamic therapy for pre-malignant conditions of the esophagus: a review of

the first 32 cases, GI Grand Rounds, University of Washington, Seattle, WA 3/03

48. Barrett’s Esophagus and adenocarcinoma of the esophagus, Idaho Gut Club, Sun

Valley Idaho, 3/03

49. Endoscopic therapy for early esophageal malignancies and dysplasia, Idaho Gut

Club, Sun Valley Idaho, 3/03

50. Endoscopic therapy for early esophageal malignancies and dysplasia, Tacoma,

Washington, 3/03

51. Photodynamic therapy for early esophageal neoplasms, Gastroenterology Grand

Rounds, University of Colorado Health Sciences Center, Denver, CO 1/03

52. Photodynamic therapy for gastrointestinal malignancies. Quebec Gut Club, Mont

Ste. Michelle, Quebec, 9/02

53. Photodynamic therapy for gastrointestinal malignancies. Everett Gut Club,

Everett, Washington, 3/02

54. Endoscopic therapies for esophageal cancer and pre-malignant conditions: What

we can, should and should not do. Esophageal Cancer 2001: Managing the

epidemic. Virginia Mason Medical Center, Seattle, 2001

55. Photodynamic therapy for esophageal lesions, American Society for Laser

Medicine and Surgery, New Orleans, 2001

56. Photodynamic therapy for esophageal lesions, American Society for Laser

Medicine and Surgery, Reno, 2000.

57. Endoscopic ultrasound for gastrointestinal malignancies, Virginia Mason Medical

Center Grand Rounds, Seattle, 9/98

Posters/Abstracts:

1. Schembre D, Ross A, Kozarek R, Yield of Double Balloon Enterosocopy versus

Spirus Enteroscopy in Occult Small Bowel Bleeding (Poster) DDW Chicgao, IL

2009

2. Schembre D, Arai A, Levy S, Farrell-Ross M, Low D. Quality of Life after

Esophagectomy and Endoscopic Therapy for Barrett’s Esophagus with High-

Grade Dysplasia or Intra-Mucosal Carcinoma, (Poster) DDW San Diego, CA

2008

3. Schembre D, Ayub K, Gibbons E, Simmons S, Hampson NB. Noninvasive

monitoring for methemoglobinemia after topical application of benzocaine during

upper endoscopy and trans-esophageal echocardiography, (Poster) DDW

Washington DC, 2007

4. Schembre, D, Ayub K, Jiranek, G. Endoscopic Mucosal Resection (EMR)

Changes Staging for Early-stage Neoplasia in Barrett’s Esophagus Compared to

Pinch Biopsies and EUS (poster) DDW, Los Angeles, 2006

5. Schembre D, Kozarek R, Use of a Self-Expanding, Removable, Plastic Stent

(Polyflex®) for Esophageal Fistulae, Perforations and Benign and Malignant

Strictures: Early Experience at a Single Institution. (poster) DDW, Chicago, 2005

6. Schembre D, Fotoohi M, Gluck M, Picozzi V, Kozarek R. Photodynamic Therapy

(PDT) for Unresectable Cholangiocarcinoma: A Single Center Experience.

(poster) DDW, Chicago, 2005

7. Schembre D, Lin O, Brandabur J, et al. Creation of a colonoscopy screening clinic

for improving endoscopy unit efficiency (poster) DDW, New Orleans, LA, 2004

8. Schembre D, Wilbur P, Kozarek R, et al. Introducing manufacturing efficiency

tools to the endoscopy suite: how the Toyota model helps drive endoscopes.

(poster) DDW, New Orleans, LA, 2004

9. Schembre D, Fenske M. “Ultra-jumbo” biopsies for sampling Barrett’s mucosa in

surveillance and post-ablation therapy patients. (poster) DDW, New Orleans, LA,

2004

10. Breitinger A, Schembre D, Mergener K, et al. Can non-endoscopists screen

capsule endoscopy findings? (poster) American College of Gastroenterology,

Seattle, 10/02

11. Schembre D, Robinson D, Guinee D. EUS guided injection of cyanoacrylate glue

into a disconnected pancreatic duct. (poster) 2002, EUS 2002, New York

12. Schembre D, Belz M, Larson L. EUS diagnosis of swallow-induced tachycardia:

A unique approach to an unusual problem. (poster) 2002, Digestive Disease

Week, San Francisco

13. Schembre D. Photodynamic therapy for pre-malignant conditions of the

esophagus: a review of the first 26 cases. (poster) 2002, Digestive Disease Week,

San Francisco

14. Schembre D, Chak A, Lightdale C, Stevens P, Sivak M. Prospective evaluation of

balloon sheath for ultrasound catheter system. (poster) 1998, Digestive Disease

Week, New Orleans.

15. Schembre D, Lightdale C, Ligresti R, Stevens P. Photodynamic therapy for high

grade dysplasia and early adenocarcinoma of the esophago-gastric junction and

gastric cardia in elderly patients with short segment Barrett’s esophagus. (poster)

1998, Digestive Disease Week, New Orleans.

16. Sahai A, Schembre D, Lightdale C, Hawes R, Sivak M. EUS-guided fine-needle

aspiration with the Olympus GFUM30P echoendoscope and the Olympus

MAJ363 FNA-needle system safely and effectively obtains diagnostic cytological

specimens in patients with suspected malignancy. (poster) 1998, Digestive

Disease Week, New Orleans.

17. Schembre D, Cannon-Albright L, Burt R, Do Age and Subsite Location Increase

Familial Risk of Colon Cancer? (Poster), Digestive Disease Week, New Orleans,

May 18, 1994

Book Chapters

1. Coding Primer: A guide for gastroenterologists. Editor Glenn Littenberg, co-

editor, Drew Schembre 2009, ASGE Press.

2. Schembre D. Recent Advances in the Use of Stents for Esophageal Disease.

Gastrointestinal Endoscopy Clinics of North America, 2009;20:103-21.

3. Schembre D. Photodynamic therapy of the gastrointestinal tract beyond the

esophagus. Advances in photodynamic therapy: Basic, translational and clinical.

Chapt 24. Ed Michael R. Hamblin, Pawel Mroz. Artech House, Boston, 2008

4. Schembre D. Role of endoscopic ultrasound for diagnosis and differential

diagnosis of neoplastic lesions. The Pancreas: An integrated textbook of basic

science, medicine and surgery, Second edition. Chapt 62. Ed. Hans Beger,

Andrew Warshaw Markus Buchler, Richard Kozarek et al. Blackwell Publishing,

Malden, MA, 2008.

5. Schembre D. Dilation and stenting of the gastrointestinal tract. Gastroenterology

and Hepatology: the Modern Clinician’s Guide. Chapt 154. Ed. Wildred

Weinstein, C.J. Hawkey, Jamie Bosch. Elsevier Science, London, 2004

Reviews, Letters and Editorials:

1. Schembre DB, Ross AS. Spiral Enteroscopy: A new twist on overtube-assisted

endoscopy. Gastrointestinal Endoscopy, 2009;69:333-336.

2. Lin O, Schembre D. Are split bowel preparation regimens practical for morning

colonoscopies? Implications of the new american college of gastroenterology

colon cancer screening guidelines for real-world clinical practice. Am J

Gastroenterol. 2009;104:2627-8

3. Schembre D, Ayub K, Jiranek G. High-frequency mini-probe ultrasoundL the

Rodney Dangerfield of endoscopy? J Clin Gastroenterol, 2005;39:555-6.

Articles:

1. Schembre D, Gluck M, Lin O, et al. Use of a threaded overtube to complete

colonoscopy in the redundant colon. Gastrointest Endososc 2011;73:515-519.

2. Schembre D. Multi-focal Metastatic Renal Cell Cancer Presenting as GI Bleeding

with Resolution by Endoscopic Resection. 2011, Swedish Medical Center

Bulletin.

3. Kuppusamy MK, Felisky C, Kozarek RA, Schembre D, et al. Impact of

endoscopic assessment and treatment on operative and non-operative management

of acute oesophageal perforation. Br J Surg 2011;98:818-824.

4. Schembre D, Dever J, Glenn M, et al. Esophageal Reconstitution by Simultaneous

Antegrade-Retrograde Endoscopy: Reestablishing patency of the completely

obstructed esophagus. Endoscopy 2011;43:434-437.

5. Story B, Thirlby R, Schembre D. Diagnosis of ileal dysplasia in a patient with

Crohn's disease by using retrograde enteroscopy with an overtube: a case report.

Gastrointest Endosc 2011;73:178-179.

6. Schembre D. Advances in Esophageal Stenting. Advan Therapy 2010;27:413-

425.

7. Schembre D, Arai A, Farrel-Ross M, Low D. Quality of life after esophagectomy

and endoscopic therapy for Barrett's esophagus with dysplasia. Dis Esoph

2010;23:458-464.

8. Schembre D. Endotherapy for Barrett’s Esophagus with High-Grade Dysplasia

and Intramucosal Carcinoma. Journal of Gastrointestinal Surgery 2009;13:1172-8.

9. Schembre DB, Huang J, Lin OS, Cantone N, Low D. Endotherapy versus

Esophagectomy for Barrett’s Esophagus with High-Grade Dysplasia or Intra-

mucosal Carcinoma. Gastrointest Endosc 2008; 67:595-601.

10. Ross A, Mehdizadeh S, Tokar

J, Leighton J, Kamal A, Chen

A, Schembre D, Chen

G, Binmoeller K, Kozarek

R, Waxman

I, Dye

C, Gerson

L, Harrison

ME, Haluszka O, Lo S, Semrad

C. Double Balloon Enteroscopy Detects Small

Bowel Mass Lesions Missed by Capsule Endoscopy. Dig Dis Sci 2008;53: 2140-

3.

11. Schembre D, Brill JV, Littenberg G, Cameron RB. Coding for “deep

ennteroscopy” procedures in an era of emerging technology. Gastrointest Endosc

2008;67:391-393.

12. Karbowski M, Schembre D, Kozarek R, Ayub K, Low D. Polyflex sef-expanding,

removable plastic stents: Assessment of treatment efficacy. Surgical Endoscopy

2008;22:1326-33.

13. Low D, Kunz S, Schembre D, et al. Esophagectomy—It’s Not Just About

Mortality Anymore: Standardized Perioperative Clinical Pathways Improve

Outcomes in Patients with Esophageal Cancer. J Gastrointest Surg 2007;11;1873.

14. Lin O, Schembre D, Ayub K, et al. Patient satisfaction scores for endoscopic

procedures: impact of a survey-collection method. Gastrointestinal Endoscopy

2007;65:775-81.

15. Lin OS. Brandabur JJ. Schembre DB. Soon MS. Kozarek RA. Acute symptomatic

small bowel obstruction due to capsule impaction. Gastrointestinal Endoscopy.

2007;65:725-8.

16. Lin OS, Schembre DB, Mergener K, Spaulding W, Lomah N, Ayub K, Brandabur

JJ, Bredfeldt J, Drennan F, Gluck M, Jiranek GC, McCormick SE, Patterson D,

Kozarek RA. Blinded comparison of esophageal capsule endoscopy versus

conventional endocsopy for a diagnosis of Barrett’s esophagus in patients with

chronic gastroesophageal reflux. Gastrointest Endosc 2007;65:577-583.

17. Lin O, Brandabur J, Schembre D. Acute symptomatic small bowel obstruction

due to capsule impaction . Gastrointest Endosc, 2007;65:725-728

18. Mehdizadeh S, Ross A, Gerson L, Leighton J, Chen A, Schembre D, Chen G,

Semrad C, Kamal A, Harrison EM, Binmoeller K, Waxman I, Kozarek R, Lo SK.

What is the learning curve associated with double-balloon enteroscopy? Technical

details and early experience in 6 U.S. tertiary care centers. Gastrointest Endosc,

2006;64:740-50.

19. Lin OS, Kozarek RA, Schembre DB, Ayub K, Gluck M, Cantone N, Soon MS,

Dominitz JA. Risk stratification for colon neoplasia: screening strategies using

colonoscopy and computerized tomographic colonography. Gastroenterology,

2006;131:1011-9.

20. Clark CJ, Thirlby RC, Picozzi V, Schembre DB, Cummings FP, Lin E. Current

Problems in surgery: gastric cancer. Curr Probl Surg, 2006;43:566-670.

21. Wolfsen H, Canto M, Etemad B, Greenwald B, Gress F, Schembre D, Bare fiber

photodynamic therapy using porfimer sodium for esophageal disease.

Photodiagnosis and photodynamitc therapy 2006;3:87-92.

22. Lin OS, Kozarek RA, Schembre DB, Ayub K, Gluck M, Drennan F, Soon MS,

Rabeneck L. Screening colonoscopy in very elderly patients: prevalence of

neoplasia and estimated impact on life expectancy. JAMA, 2006;295:2357-65.

23. Cotton PB, Hawes RH, Barkum A, Ginsberg GG, Amman S, Cohen J, Ponsky J,

Rex DK, Schembre D, Wilcox CM. Excellence in endoscopy: toward practical

metrics. Gastrointest Endosc, 2006;63:286-91.

24. Lin OS, Schembre DB, McCormick SE, Gluck M Patterson DJ, Jiranek GC Soon

MS, Kozarek RA. Risk of proximal colorectal neoplasia among asymptomatic

patients with distal hyperplastic polyps. Am J Med, 2005;118:1113-9.

25. Lin OS Gerson LB, Soon MS, Schembre DB, Kozarek RA. Risk of proximal

neoplasia with distal hyperplastic polyps: a meta-analysis. Arch Intern Med,

2005;165:382-90.

26. Mosler P, Mergener K, Brandabur J, Schembre D, Kozarek R. Paliation of gastric

outlet obstruction and proximal small bowel obstruction with self-expanable

metal stents: a single center series. 2005;39:124-128.

27. Soon MS, Soon A, Schembre D, Lin O. Prospective evaluation of a jelly-like

conducting medium for catheter endosonographic imaging of the esophagus.

Gastrointest Endosc, 2005;61:133-139.

28. Schembre D. Smart Endsocopes. Gastrointestinal Endosc Clinics of North

America, 2004;14:709-716.

29. Schembre D. Photodynamic therapy for esophageal cancer. Visible human journal

of endoscopy. (on-line journal www.vhjoe.com), Vol 3(1).

30. Schembre D, Lin O. The Frequency and Costs of Echoendoscope Repairs: Results

of a survey of endosonographers: results of a survey of endosonographers.

Endosocopy, 2004;36:982-986.

31. Schembre D, Endoscopic therapeutic esophageal interventions: old, new,

borrowed and …methylene blue? Current Opinion in Gastroenterology, 2003,

19:394-399.

32. Schembre D, Endoscopic therapeutic esophageal interventions, Current Opinion

in Gastroenterology, 2002;18:479-485.

33. Mergener K, Brandabur J, Schembre D. Capsule endoscopy—A new procedure

for evaluation patients with obscure gastointestinal bleeding. Virginia Mason

Medical Center Bulletin, 2002;56:30-33.

34. Schembre D. Endoscopic ablative therapies for malignant esophageal strictures.

Techniques in Gastrointestinal Endoscopy, 2001;3:159-165.

35. Schembre D, Endoscopic therapeutic esophageal interventions, Current Opinion

in Gastroenterology, 2001;17:387-92.

36. Gluck M, Schembre D, Kozarek R, A concern with use of the “push technique” in

patients with multiple esophageal rings, (letter), Gastrointestinal Endoscopy,

2001;54:543-4.

37. Schembre D, Infectious Complications Associated with Gastrointestinal

Endoscopy, Gastrointestinal Endoscopy Clinics of North America, 2000;10:215-

232.

38. Schembre D, Chak A, Lightdale C, Stevens P, Sivak M. Prospective evaluation of

balloon sheath for ultrasound catheter system. Gastrointestinal Endoscopy,

2001;53:758-61.

39. Kozarek R, Attia F, Schembre D, et al, Reusable biopsy forceps: a prospective

evaluation of cleaning, function, adequacy of tissue specimen, and durability.

Gastrointestinal Endoscopy, 2001;53:747-50.

40. Schembre D, Kozarek R, Endoscopic therapeutic esophageal interventions,

Current Opinion in Gastroenterology, 2000;16:380-5.

41. Schembre D, Gluck M, Neuzil, D. Endoscopic Ultrasound findings of linitis

plastica. Virginia Mason medical center bulletin 2000, 54:29-32

42. Sahai A, Schembre D, Lightdale C, Hawes R, Sivak M. EUS-guided fine-needle

aspiration with the Olympus GFUM30P echoendoscope and the Olympus

MAJ363 FNA-needle system safely and effectively obtains diagnostic cytological

specimens in patients with suspected malignancy. Gastrointestinal Endoscopy

1999;50:792-6.

43. Schembre D, Picozzi V, Cha C, Esophageal cancer: New diagnostic and

therapeutic approaches, Virginia Mason Bulletin 1999;53:1-16.

44. Schembre D, Boynton, K. Ischemic colitis caused by diet medications. (letter)

New England J Med, 1997;336:510-11.

45. Schembre D, Bjorkman D. A rational approach to giving antibioptic prophylaxis

before endoscopy. Who needs it?. Journal of Critical Illness 1995;10:259-61.

46. Burt RW, Schembre D. Advancements in the Genetics of Colorectal Cancer.

Implications for diagnosis and therapy. Practical Gastroenterology. 1994;18:12C-

12O.

http://www.vhjoe.com/

47. Schembre D, Bjorkman DJ. Endoscopy Related Infections. Alimentary

Pharmacology and Therapeutics, 1993;7:347-55.

48. Schembre D, Bjorkman DJ. Post-Sclerotherapy Bacterial Peritonitis. Am J

Gastroenterol. 1991;86:481-486.

49. Schembre D, Lazaro EJ. Dermatobia hominis Myiasis Masquerading as an

Infected Sebaceous Cyst. Canadian J Surg. 1990;33:145-6.

50. Schembre D. Scut is a Four Letter Word. Pulse (in JAMA, medical student

editions) 1987;257:iv.

51. Schembre D. License to Practice. Pulse (JAMA) 1986;256:iv.

52. Schembre D. The Best Medicine. Pulse (JAMA) 1986;256:iv.

Washington State

Health Care Authority Health Technology Assessment Program

Upper Endoscopy – Final Comments – April 12, 2112 1

Overview of Public Comments and Response

Upper Endoscopy for GERD

April 2012

Center for Evidence-based Policy Oregon Health & Science University

3455 SW US Veterans Hospital Road Mailstop SN-4N, Portland, OR 97239-2941

Phone: 503.494.2182 Fax: 503.494.3807

http://www.ohsu.edu/ohsuedu/research/policycenter/med/index.cfm

http://www.ohsu.edu/ohsuedu/research/policycenter/med/index.cfm

Washington State

Health Care Authority Health Technology Assessment Program

Upper Endoscopy – Final Comments – April 12, 2112 2

Draft Key Questions Overview of Public Comments and CEbP Response

Submitted By Cited Evidence

Overview of Public Comment CEbP Response

Karen Anderson, MD, MPH

No Recommended eliminating key question #1 and #2 Recommended changing key question #3 from

“…Does repeat endoscopy change treatment and outcome?” to “…Does endoscopy (initial or repeat) change treatment and outcome?”

For key question 5, recommended adding under (d) individuals known to ingest alcohol chronically

Thank you for your comments. The Key Questions address specific items of interest to the HTA clinical committee as outlined.

Key Question #3 is focused specifically on repeat endoscopy.

We have amended Key Question #5 item e as follows: e. Other patient characteristics or evidence based patient selection criteria, especially comorbidities of diabetes, high BMI, and chronic ingestion of alcohol.

Draft Report

No public comments were received on the draft report.

Agency Medical Director CommentsHealth Technology Clinical Committee

Upper Endoscopy(EGD) for GERD and GI Symptoms

G. Steven Hammond PhD, MD, MHAChief Medical OfficerDepartment of CorrectionsMay 18, 2012

2

• GERD and GI Symptoms are extremely common in the primary care setting (estimated prevalence 10‐58%)

• Upper endoscopy (esophagogastroduodenoscopy or EGD) is a moderately expensive and invasive procedure.

– Coverage policy and guidelines are helpful to direct rational utilization management procedures

Upper Endoscopy for GERD Background

3

AMDG Perspective

Evidence review upon which to base coverage policy and utilization management is sought

Upper Endoscopy for GERD Background

4

Upper Endoscopy for GERDCurrent State Agency Policy

L&I allows Upper Endoscopy for GERD

UMP allows Upper Endoscopy for GERD

Medicaid Policies allow Upper Endoscopy for GERD

5

State Agencies Questions

– Safety: Concern level low • However:

–Overly aggressive management may expose patients to risk of harm from unnecessary diagnostic procedures and treatment

• Yet:–What is the risk of overly conservative management?

»Missed diagnosis leading to worse health outcomes?


6

State Agencies Questions

– Effectiveness: Concern level medium‐high• What is the benefit of early and/or repeated upper endoscopies on health outcomes?

– Cost: Concern level medium‐high• Given the high prevalence of GERD/dyspepsia, potential utilization of upper endoscopy is high

• An evidence‐based approach to control of utilization would aim at avoiding wasted healthcare resources while optimizing health outcomes


7

Upper Endoscopy for GERDBilling Codes

Diagnosis (Dx) Codes Likely to Indicate GERD(Sample Diagnoses)

Objective Findings Based Dx General Symptoms Based Dx

530.1 Esophagitis 536.8Dyspepsia and other specified disorders of function of stomach

530.11 Reflux esophagitis 787.1 Heartburn530.81 Esophageal reflux 787.2 Dysphagia, NOS 530.85 Barrett's esophagus 787.21 Dysphagia, oral

535.0Acute gastritis, without mention of hemorrhage

789.06 Abdominal pain, epigastric

8

Upper Endoscopy for GERD State Agency Utilization

2007 2008 2009 2010

PEB Total Population 172,009 204,804 210,501 213,487

% of Total Population w/ GERD Dx 14.0% 13.9% 14.0% 13.6%% of Total Population w/ EGD 2.7% 2.7% 2.9% 2.8%% of Total Pop. w/ UE for GERD 1.5% 1.5% 1.5% 1.4%Medicaid Total FFS Population 378,915 392,808 416,871 424,230% of Total Population w/ GERD Dx 15.1% 15.1% 15.3% 15.1%% of Total Population w/EGD 2.1% 2.0% 2.3% 2.7%% of Total Pop. w/UE for GERD 1.1% 1.1% 1.2% 1.4%

Note: Figures not available for L&I

L&I Claimant counts 2007 2008 2009 2010All claimants w GERD 1234 1163 1099 1039All GERD Dx Upper Endoscopies 46 46 51 32

% 3.73% 3.96% 4.64% 3.08%9


PEB Member counts 2007 2008 2009 2010All members w GERD Diagnosis (Dx) 24035 28529 29546 29050All GERD Dx Upper Endoscopies 2531 2997 3196 3077

% 10.5% 10.5% 10.8% 10.6%

Medicaid Patient counts 2007 2008 2009 2010All patients w GERD 57332 59268 63851 63994All GERD Dx Upper Endoscopies 4093 4199 5016 6031

% 7.1% 7.1% 7.9% 9.4%

10


Upper Endoscopies w/ GERD Diagnoses 2007 2008 2009 2010 4 year

overallPEB: Total Paid $1.6M $2.0M $2.4M $2.3M $8.3MPatient Count 2578 3087 3366 3335 12366Max paid /proc $4,896 $4,677 $4,964 $6,030 $6,030Avg/ proc $611 $667 $702 $683 $669Avg/ proc

x(primary payer only) $872 $912 $978 $953 $933

Medicaid: Total Paid $1.2M $1.3M $1.6M $1.8M $5.9MPatient Ct 4093 4199 5016 6031 19339Max/proc $3,221 $4,896 $3,469 $3,604 $4,896Avg/ proc $297 $309 $327 $294 $306

L&I: Total Payments $34,577 $33,466 $36,548 $20,837 $125,429Patient Count 46 46 51 32 175Max/procedure $3,407 $1,606 $3,139 $1,679 $3,407Avg/procedure $752 $728 $717 $651 $717

11


2007 2008 2009 2010 2011

All Upper Endoscopies (UE)

4662 5569 6010 5998

All GERD Diagnosis UE 2578 3087 3366 3335GERD % of all UE 55.3% 55.4% 56.0% 55.6%

010002000300040005000600070008000

PEB Patient Counts for Upper Endoscopy (UE),2007‐2010

9.3%/yr avg

9.0%/yr avggrowth

12


2007 2008 2009 2010 2011

All Upper Endoscopies (UE)

7794 7899 9457 11481

All GERD Diagnosis UE 4093 4199 5016 6031GERD % of all UE 52.5% 53.2% 53.0% 52.5%

0

2000

4000

6000

8000

10000

12000

14000

Medicaid Patient Counts for Upper Endoscopy, 2007‐2010

14.2%/yr avg growth

14.1%/yravg growth

13


2007 2008 2009 2010

All Upper Endoscopies (UE) $2,707,776 $3,568,862 $4,135,016 $4,083,934All GERD Dx endoscopies $1,576,355 $2,058,633 $2,363,815 $2,277,442% GERD in all UE 58.2% 57.7% 57.2% 55.8%

$0.0

$1.0

$2.0

$3.0

$4.0

$5.0

$6.0

Millions

PEB Payments for Upper Endoscopy, 2007‐2010

13.9%/yr avggrowth

15.5%/yr avg growth

14


2007 2008 2009 2010 2011

All Upper Endoscopies (UE) $2,299,776 $2,361,653 $2,980,410 $3,250,317All GERD Diagnosis UE $1,215,982 $1,297,634 $1,640,671 $1,772,311GERD % of all UE 52.9% 54.9% 55.0% 54.5%

$0.0

$0.5

$1.0

$1.5

$2.0

$2.5

$3.0

$3.5

$4.0

Millions

Medicaid Payments for Upper Endoscopy, 2007‐2010

12.6%/yr avg growth

13.7%/yr avggrowth

15


0200400600800

100012001400160018002000

2007 2008 2009 2010

PEB Patient Counts for General Symptoms vsObjective Findings Dx GERD EGD, 2007‐2010

General Symptoms

Objective Diagnoses

16


0

500

1000

1500

2000

2500

3000

3500

4000

2007 2008 2009 2010

Medicaid Patient Counts for General Symptoms vsObjective Findings Dx GERD EGD 2007‐2010

General SymptomsObjective Diagnoses

17


Procedures Patients 16 112 110 29 18 47 86 95 194 623 2312 1156

1 (no rpt) 8809 (71%)

PEB Patients with Repeated Endoscopies with GERD Diagnoses(4 years data, 12366 total patients)

Medicaid Patients with Repeated Endoscopies with GERD Diagnoses(4 years data, 19339 total patients)

Procedures Patients 17 116 115 114 410 89 48 67 136 155 104 423 832 350

1 (no rpt) 18,801 (97%)

18

Medicare – NCDCovered “when reasonable and necessary for the individual patient” – note this is an old coverage decision [per CMS website “longstanding… effective date… not posted”] and not evidence based

Aetna –Covered for specified indications

BCBS –Covered, no restrictions

Upper Endoscopy for GERD: Other Centers, Agencies and HTAs

19

Upper Endoscopy for GERD: Risks & Benefits

• Possible benefit– Objective evaluation of condition diagnosed on basis of symptom report

– Possible early detection of condition with serious health outcome sequelae that can be mitigated by early detection

• Risk– Wasted healthcare resources with little if any potential benefit

Upper Endoscopy for GERD: Evidence Summary

The evidence shows:• Early endoscopy for general upper GI symptoms compared to

trial of treatment does not appear to improve outcomes

• Certain factors, such as “alarm symptoms”, (e.g., anemia, unintentional weight loss, intractable vomiting, dysphagia) and more advanced age, while not strongly predictive of more serious pathology, may be a reasonable indication for endoscopy

• In absence of objective findings, there is little evidence to support repeat endoscopy

• Risk of foregoing endoscopy in presence of alarm symptoms or advanced age uncertain

20

21

State Agencies Summary View– GERD and related upper GI symptoms are very common

• Benefit of early endoscopy for upper GI symptoms, in absence of alarm symptoms or advanced age, not evident

• Repeat endoscopy in absence of objective findings not supported

• Endoscopy in presence of advanced age or alarm symptoms may be prudent in absence of strong evidence otherwise

Upper Endoscopy for GERD Summary

22

State Agencies Recommendation– Cover with Conditions

• Failure of trial of treatment to improve or resolve symptoms OR

• Presence of alarm symptoms or advanced age (>55 years) OR

• Objective findings of serious upper GI pathology (e.g., ulceration, stricture, dysplasia)


Questions?

More Information:http://hta.hca.wa.gov

23

http://hta.hca.wa.gov/

Upper Endoscopy for GastroesophagealReflux Disease (GERD) and Upper

Gastrointestinal (GI) Symptoms

Presented by : Robyn Liu, MD, MPHCenter for Evidence-based PolicyDate: May 18, 2012

Center for Evidence-based PolicyAddressing Policy Challenges With Evidence and Collaboration

Introduction

• Background• Methods• Key Questions• Findings• Guidelines• Coverage Policies• Summary

2


Background – Clinical Overview

• Dyspepsia--encompasses one or more of: – Epigastric pain or burning– Postprandial fullness and/or early satiety– Nausea and vomiting– Upper abdominal bloating– Heartburn and/or regurgitation

• GERD: “a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications” (Montreal Consensus Panel definition, cited in Vakil 2006)

3


Background – Clinical Overview

4

Image: digestivediseaseny.com

• Esophagogastroduodenoscopy (EGD or Upper GI Endoscopy) is used to distinguish GERD and dyspepsia from more serious pathology (adenocarcinoma, Barrett’s Esophagus, etc)

• Other diagnostic tools include symptom questionnaires, empiric therapeutic trials, pH monitoring


PICO

• Population: Adults with an initial presenting complaint of upper gastrointestinal symptoms and/or GERD

• Intervention: Upper gastrointestinal endoscopy

• Comparator: Medical management without endoscopy – including screening questionnaires, noninvasive H. pylori testing, empiric acid-suppression therapy

• Outcome: Clinical symptom resolution (e.g., as measured by symptom scoring tools), health care resource utilization, development of serious gastrointestinal pathology (e.g. malignancy, Barrett’s esophagus, esophageal stricture), quality of life indicators

5


Key Questions

• KQ#1:What is the evidence of effectiveness for early treatment strategies that include upper endoscopy compared with empiric medical management?

• KQ #2:Are there clinical signs and symptoms useful to identify patients for whom early endoscopy is effective to improve health outcomes and/or disease management?

6


Key Questions

• KQ#3:For what diagnoses and within what time frames, is repeat endoscopy indicated versus other tests or no follow-up tests for surveillance of disease progression and/or treatment response? Does repeat endoscopy change treatment and outcome?

• KQ#4: What are the potential harms of performing upper endoscopy in the diagnostic or treatment planning workup of adults with upper GI symptoms? What is the incidence of these harms? Include consideration of progression of treatment in unnecessary or inappropriate ways.

7


Key Questions

• KQ#5: What is the evidence that upper endoscopy has differential efficacy or safety issues in sub-populations? Including consideration of: – a. Gender – b. Age – c. Psychological or psychosocial co-morbidities – d. Other patient characteristics or evidence based patient

selection criteria, especially comorbidities of diabetes, high BMI, and chronic ingestion of alcohol

– e. Provider type, setting or other provider characteristics– f. Payer / beneficiary type including worker’s compensation,

Medicaid, state employees

8


Key Questions

• KQ#6:What is the evidence of cost and cost-effectiveness of endoscopy compared to other treatment strategies when used in diagnostic or treatment planning workups of adults with upper GI symptoms?

9


Methods – Search Strategy

• Systematic reviews (SRs) and technology assessments (TAs) identified using a “best evidence” SR methodology

• The most recent and comprehensive, high-quality SR/TA identified was updated by a MEDLINE literature search for individual studies

• If SR/TAs were not identified, a 10 year search for individual studies was completed (January 2002 to January 2012)

• A 5 year search for guidelines used CEbP core sources• Relevant policies were identified on CMS, Aetna, BCBS,

and Group Health websites

10


Methods – Search Strategy (cont)

• For Key Question #6, all relevant economic evaluations, cost-effectiveness analyses, and economic simulation models were included.

• Exclusion criteria for all KQ’s:– Long-term treatment of GERD– Confirmed Barrett’s esophagus (BE) diagnosis– Wireless capsule endoscopy– Prior GI and anti-reflux surgeries– Studies of exclusively Asian populations

11


Methods – Quality Assessment

• Methodological quality of the studies were assessed with instruments adapted by CEbP based on those used by NICE and SIGN– Studies were rated as good, fair, or poor for minimization of bias

• Methodological quality of the guidelines were assessed using an instrument adapted and developed by CEbP from the AGREE Collaboration– Guidelines rated as good, fair, or poor based on methodology

and potential for bias

12


Methods – Quality Assessment (cont)

• Methodological quality of the economic studies was rated using an instrument adapted by CEbP that incorporates modifications of the BMJ, CHEC, and NICE economic evaluation checklists– Studies were rated as good, fair, or poor based on methodology

and potential for bias

• The modified GRADE system was used to rate the overall strength of evidence – Evidence was rated as high, moderate, low, and very low for

each key question and outcome

13


Results – Literature Search

• ~ 1400 citations were reviewed

• Most studies were retrospective observational cohort studies

• 3 SRs and 7 articles met inclusion criteria

• 4 relevant guidelines

14


KQ #1: Effectiveness of EGD

• Good-quality SR (Delaney 2005) with MA (5 RCTs) of PPI vs. early endoscopy– No difference in symptomatic cure at 12 months

• Same SR with MA (5 RCTs) of early endoscopy vs. test-and-treat (T&T) for H. pylori– Trial-level data: No difference in effect but high heterogeneity– Individual Patient Data (IPD) analysis: small, statistically

significant benefit to early endoscopy (RR 0.95, 95% CI 0.92 to 0.99)

15


KQ #1: Effectiveness of EGD (cont)

• Fair-quality cohort study of 6 tests for GERD (Madan2005)– 24-hour pH monitoring most sensitive single test – Sequential PPI challenge, endoscopy, biopsy 100% sensitive

• Overall, evidence indicates that endoscopy is not superior to non-invasive strategies for diagnosis and management of upper GI symptoms

• Strength of evidence: High

16


KQ #2: Identifying EGD candidates

• Good quality SR, including 17 cohort studies (fair to good quality) (Vakil 2006)– Alarm symptoms, clinical opinion, computer modeling programs

are all poor predictors of malignancy– Cutoff age >55 “most logical alternative strategy”

• Good quality prospective cohort study, n=4,329 (Marmo2005)– Diagnostic yield (malignancy) of endoscopy increased for males

>35 and females >57 years old– 69.8% of cancer patients have alarm symptom– 0.9% of pts without alarm symptoms have cancer

17


KQ #2: Identifying EGD candidates (cont)

• Fair quality prospective cohort study (Rossi 2002)– Endoscopy pre-test probability of “relevant endoscopic

diagnosis” including malignancy, BE, erosions; 47% if ASGE GL criteria present, 29% if absent

• Fair quality prospective cohort (Bowrey 2005) – 15% of patients with carcinoma had no alarm symptoms

• Fair quality prospective cohort (V. van Zanten 2006)– BE most likely in males, >50 years old, reflux-predominant, >5 yr

symptom duration

• Strength of evidence: Moderate

18


KQ #3: Indications for repeat endoscopy

• Good quality prospective cohort study (n=302) (Westbrook 2005) – Dyspeptic patients with non-malignant findings on index

endoscopy– 1/3 had repeat endoscopy within 9 years– No difference in symptoms based on repeat endoscopy

• Strength of evidence: Low

19


KQ #4: Harms of endoscopy

• Most SRs, MAs and EEs failed to report harms• One good quality EE (Spiegel 2002) used a 0.02%

incidence of severe harms – Cost modeled on surgical repair of perforation

• Strength of evidence: Low

20


KQ #5: Differential efficacy or safety

• Good-quality SR (Ford 2005) with IPD MA (5 RCTs, n=1924) looked at age, gender, dominant symptom, and H. pylori status – Small, significant benefit of endoscopy for symptom relief in >50

year old patients; no other associations

• Good-quality cohort study (Marmo 2005)– On average, patients with malignancy are 20 years older

• Fair-quality cohort study (Bowrey 2005)– Prevalence of malignancy rises with age

21


KQ #5: Differential efficacy or safety (cont)

• Good-quality EE model (Barton 2008)– Relative effectiveness same in 30-year-olds as 60-year-olds

• Poor-quality retrospective chart review (Connor 2004)– No correlation between all significant endoscopic findings and

age, gender, race, or NSAID use

• Strength of evidence: Moderate (Age); Very Low (others)

22


KQ #6: Cost and cost-effectiveness

• H. pylori test-and-treat (T&T) favored by 7 of 10 studies • One good quality economic evaluation (Barton 2008)

favored empiric PPI for US 30-year-olds but T&T for 60-year-olds

• Good quality economic evaluation of Canadian data found no one strategy clearly cost effective, but “CanDys” protocol best at WTP CAN$30,000 to CAN$70,000/QALY– Protocol incorporates empiric PPI for heartburn/reflux predominant

patients, test-and-treat for others

• Strength of evidence: Moderate

23


Acceptability Curve (Barkun 2008)

24


KQ #6: Cost and cost-effectiveness (cont)

Empiric PPI H. pylori Test & Treat Questionnaire

Good Quality• Barton 2008, US (preferred strategy for

hypothetical 30yo pop.)• Barton 2008, US (preferred strategy for

hypothetical 60yo pop.)• Makris 2003, Canada (preferred strategy for both

hypothetical 18‐45yo and ≥45yo pops.)• You 2006, Hong Kong (hypothetical ≥18yo pop.)• Barkun 2010, Canada (individual data from 2,236

Canadians ≥18yo)• Spiegel 2002 (T&T PPI EGD is the preferred

strategy in US patients < 45 yo)• Ford 2005 (IPD meta‐analysis of Cochrane data)

Fair Quality

• Duggan 2008, UK (762 adults ≥18yo presenting to primary care with dyspepsia)

• Garcia‐Altes 2005, Spain (hypothetical ≥18yo pop.)

Poor Quality

• Giannini 2008, Italy (612 adults ≥18yo presenting to GI centers with ≥3mo of symptoms)

• Kjeldsen 2007, Denmark (368 adults ≥18yo presenting to primary care with dyspepsia)

Note: Neither study included a comparison with H. pylori test‐and‐treat

• Klok 2005, Netherlands (281 adults ≥18yo presenting to primary care with dyspepsia)

25


Guidelines

• AGA, 2008, good quality – Endoscopy recommended for GERD unresponsive to treatment– Recommends against routine endoscopy for surveillance of GERD

• ASGE, 2007a, fair quality – Endoscopy recommended for screening of BE, recurrent reflux after

surgery, suspected extraesophageal manifestations of GERD

• ASGE, 2007b, fair quality – Recommends endoscopy for patients 45-55 years with new onset

dyspepsia and alarm symptoms; endoscopy or PPI for patients <50 with negative H. pylori testing

• ASGE, 2006, poor quality– Only perform endoscopy in elderly patients when results will influence

clinical management

26


Policy Summary

• Medicare– NCD for “endoscopy” allows coverage “when reasonable and

necessary for the individual patient”– No applicable LCDs for Washington or CMS Region X

• Aetna– Clinical Policy Bulletin Criteria (2011)

• Diagnostic (e.g., failed therapy, alarm symptoms, dysphagia, bleed)• High-risk screening (e.g., >5 yrs GERD, pernicious anemia,

cirrhosis and portal hypertension)• Surveillance (e.g., BE, adenomatous polyps, h/o caustic injury)

• GroupHealth, Regence BCBS Washington – no policies

27


Summary

• High level of evidence that upper endoscopy is not more effective for symptom relief than non-invasive strategies for uncomplicated dyspepsia

• Moderate level of evidence that endoscopy is more beneficial for symptom relief and for detection of malignancy with rising patient age

• Moderate level of evidence that “alarm symptoms,” clinical opinion, and computer-based models are poor predictors of malignancy

28


Summary (cont)

• Low level of evidence that repeat endoscopy for patients with nonmalignant findings does not improve symptom outcome

• Few data exist on harms of endoscopy

• Moderate level of evidence that H. pylori test-and-treat is most cost-effective strategy for symptom relief – Empiric PPI may be more cost-effective in younger patients

• Guidelines and policies are permissive and rely on clinical judgment

29


30

Questions or comments?

1

0BHTCC Coverage and Reimbursement Determination 1BAnalytic Tool

HTA’s goal is to achieve better health care outcomes for enrollees and beneficiaries of state programs by paying for proven health technologies that work.

To find best outcomes and value for the state and the patient, the HTA program focuses on these questions:

1. Is it safe?

2. Is it effective?

3. Does it provide value (improve health outcome)?

The principles HTCC uses to review evidence and make determinations are:

Principle One: Determinations are Evidence based

HTCC requires scientific evidence that a health technology is safe, effective and cost-effectiveF

1F

as expressed by the following standards. F

2F

Persons will experience better health outcomes than if the health technology was not covered and that the benefits outweigh the harms.

The HTCC emphasizes evidence that directly links the technology with health outcomes. Indirect evidence may be sufficient if it supports the principal links in the analytic framework.

Although the HTCC acknowledges that subjective judgments do enter into the evaluation of evidence and the weighing of benefits and harms, its recommendations are not based largely on opinion.

The HTCC is explicit about the scientific evidence relied upon for its determinations.

Principle Two: Determinations result in health benefit

The outcomes critical to HTCC in making coverage and reimbursement determinations are health benefits and harms.F

3 In considering potential benefits, the HTCC focuses on absolute reductions in the risk of

outcomes that people can feel or care about.

In considering potential harms, the HTCC examines harms of all types, including physical, psychological, and non-medical harms that may occur sooner or later as a result of the use of the technology.

Where possible, the HTCC considers the feasibility of future widespread implementation of the technology in making recommendations.

The HTCC generally takes a population perspective in weighing the magnitude of benefits against the magnitude of harms. In some situations, it may make a determination for a technology with a large potential benefit for a small proportion of the population.

In assessing net benefits, the HTCC subjectively estimates the indicated population's value for each benefit and harm. When the HTCC judges that the balance of benefits and harms is likely to vary substantially within the population, coverage or reimbursement determinations may be more selective based on the variation.

The HTCC considers the economic costs of the health technology in making determinations, but costs are the lowest priority.

1

Based on Legislative mandate: See RCW 70.14.100(2).

2 The principles and standards are based on USPSTF Principles at: Hhttp://www.ahrq.gov/clinic/ajpmsuppl/harris3.htm

3 The principles and standards are based on USPSTF Principles at: Hhttp://www.ahrq.gov/clinic/ajpmsuppl/harris3.htm

http://www.ahrq.gov/clinic/ajpmsuppl/harris3.htm

http://www.ahrq.gov/clinic/ajpmsuppl/harris3.htm

2

Using Evidence as the basis for a Coverage Decision

Arrive at the coverage decision by identifying for Safety, Effectiveness, and Cost whether (1) evidence is available, (2) the confidence in the evidence, and (3) applicability to decision.

1. Availability of Evidence:

Committee members identify the factors, often referred to as outcomes of interest, that are at issue around safety, effectiveness, and cost. Those deemed key factors are ones that impact the question of whether the particular technology improves health outcomes. Committee members then identify whether and what evidence is available related to each of the key factors.

2. Sufficiency of the Evidence:

Committee members discuss and assess the evidence available and its relevance to the key factors by discussion of the type, quality, and relevance of the evidenceF

4F using

characteristics such as:

Type of evidence as reported in the technology assessment or other evidence presented to committee (randomized trials, observational studies, case series, expert opinion);

the amount of evidence (sparse to many number of evidence or events or individuals studied);

consistency of evidence (results vary or largely similar);

recency (timeliness of information);

directness of evidence (link between technology and outcome);

relevance of evidence (applicability to agency program and clients);

bias (likelihood of conflict of interest or lack of safeguards).

Sufficiency or insufficiency of the evidence is a judgment of each clinical committee member and correlates closely to the GRADE confidence decision.

Not Confident Confident

Appreciable uncertainty exists. Further information is needed or further information is likely to change confidence.

Very certain of evidentiary support. Further information is unlikely to change confidence

3. Factors for Consideration - Importance

At the end of discussion at vote is taken on whether sufficient evidence exists regarding the technology’s safety, effectiveness, and cost. The committee must weigh the degree of importance that each particular key factor and the evidence that supports it has to the policy and coverage decision. Valuing the level of importance is factor or outcome specific but most often include, for areas of safety, effectiveness, and cost:

risk of event occurring;

the degree of harm associated with risk;

the number of risks; the burden of the condition;

burden untreated or treated with alternatives;

the importance of the outcome (e.g. treatment prevents death vs. relief of symptom);

the degree of effect (e.g. relief of all, none, or some symptom, duration, etc.);

value variation based on patient preference.

4 Based on GRADE recommendation: HUhttp://www.gradeworkinggroup.org/FAQ/index.htm UH

http://www.gradeworkinggroup.org/FAQ/index.htm

3

Medicare Coverage Organization

Date Outcome Evidence Base

Grade / Rating

Centers for Medicare and Medicaid Services CMS National Policy Decisions – Publication Number 100-3 WA HTA Page 52

”The effective date of this version has not been posted.”

Item/Service Description

Endoscopy is a technique in which a long flexible tube-like instrument is inserted into the body orally or rectally, permitting visual inspection of the gastrointestinal tract. Although primarily a diagnostic tool, endoscopy includes certain therapeutic procedures such as removal of polyps, and endoscopic papillotomy, by which stones are removed from the bile duct. Indications and Limitations of Coverage

Endoscopic procedures are covered when reasonable and necessary for the individual patient

http://go.cms.gov/K7tksU

Guidelines (Page 50 of WA HTA Report)

Guideline Recommended Use of Endoscopy Not Recommended / Insufficient

Evidence Quality

AGA (2008) [GERD]

Endoscopy with biopsy for patients with an esophageal GERD syndrome with troublesome dysphagia

Evaluation of patients who have not responded to an empirical trial of twice-daily PPI therapy and who have suspected esophageal GERD symptoms

Routine endoscopy for patients with erosive or nonerosive reflux disease to assess for disease progression (Recommends Against)

Routine upper endoscopy for chronic GERD symptoms to diminish the risk of death from esophageal cancer (Insufficient Evidence)

Screening of “Barrett’s esophagus and dysplasia in adults 50 years or older with greater than 5 to 10 years of heartburn to reduce mortality from esophageal adenocarcinoma (Insufficient Evidence)

Good

ASGE (2007a) [GERD]

Patients who have alarm symptoms

Evaluation of patients with suspected extra-esophageal manifestations of GERD

Evaluation of patients with recurrent symptoms after endoscopic or surgical antireflux procedures

Screening for Barrett’s Esophagus in selected patients as clinically indicated

GERD can be diagnosed based on typical symptoms without the need for endoscopy

Fair

ASGE (2007b) Patients between 45 to 55 years n/a Fair

http://go.cms.gov/K7tksU

4

Guideline Recommended Use of Endoscopy Not Recommended / Insufficient

Evidence Quality

[Dyspepsia] with new onset dyspepsia

Patients with alarm features

Patients without alarm features for whom there is clinical suspicion of malignancy

Patients younger than 50 years and who are H pylori negative, endoscopy or short trial of PPI acid suppression

Patients with dyspepsia who do not respond to empiric PPI therapy or have recurrent symptoms after an adequate trial

ASGE (2006) [Considerations for older population]

If results will influence clinical management or outcomes

Intensified monitoring may be appropriate for many elderly patients

n/a

Poor

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HEALTH TECHNOLOGY EVIDENCE IDENTIFICATION

Discussion Document: What are the key factors and health outcomes and what evidence is there?

Upper Endoscopy for GERD and Upper GI Symptoms

Safety Outcomes

Safety Evidence

Perforation

Efficacy / Effectiveness Evidence

Sensitivity

Specificity

Treatment planning

Diagnostic yield

Cancer detection

Cancer prevention

Special Population / Considerations Outcomes Special Population Evidence

Gender

Age

Comorbidities (including smoking, alcohol use, psychological)

BMI

Other characteristics

Provider type, setting, other

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Payer or Beneficiary Type

Cost

Cost Evidence

Total Health Care Costs / Societal Costs

Direct and indirect

Cost Effectiveness

Clinical Committee Evidence Votes

First voting question

The HTCC has reviewed and considered the technology assessment and information provided by the

administrator, reports and/or testimony from an advisory group, and submissions or comments from the

public. The committee has given greatest weight to the evidence it determined, based on objective

factors, to be the most valid and reliable.

Is there sufficient evidence under some or all situations that the technology is:

Unproven

(no) Equivalent

(yes) Less

(yes) More

(yes)

Effective

Safe

Cost-effective

Discussion

Based on the evidence vote, the committee may be ready to take a vote on coverage or further discussion

may be warranted to understand the differences of opinions or to discuss the implications of the vote on a

final coverage decision.

Evidence is insufficient to make a conclusion about whether the health technology is safe,

efficacious, and cost-effective;

Evidence is sufficient to conclude that the health technology is unsafe, ineffectual, or not cost-

effective

Evidence is sufficient to conclude that the health technology is safe, efficacious, and cost-

effective for all indicated conditions;

Evidence is sufficient to conclude that the health technology is safe, efficacious, and cost-

effective for some conditions or in some situations

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A straw vote may be taken to determine whether, and in what area, further discussion is necessary.

Second vote

Based on the evidence about the technologies’ safety, efficacy, and cost-effectiveness, it is

_______Not Covered. _______ Covered Unconditionally. _______ Covered Under Certain Conditions.

Discussion Item

Is the determination consistent with identified Medicare decisions and expert guidelines, and if not, what

evidence is relied upon.

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Clinical Committee Findings and Decisions

Next Step: Cover or No Cover

If not covered, or covered unconditionally, the Chair will instruct staff to write a proposed findings and

decision document for review and final adoption at the following meeting.

Next Step: Cover with Conditions

If covered with conditions, the Committee will continue discussion.

1) Does the committee have enough information to identify conditions or criteria?

Refer to evidence identification document and discussion.

Chair will facilitate discussion, and if enough members agree, conditions and/or criteria will be

identified and listed.

Chair will instruct staff to write a proposed findings and decision document for review and final

adoption at next meeting.

2) If not enough or appropriate information, then Chair will facilitate a discussion on the following:

What are the known conditions/criteria and evidence state

What issues need to be addressed and evidence state

The chair will delegate investigation and return to group based on information and issues identified.

Information known but not available or assembled can be gathered by staff ; additional clinical questions

may need further research by evidence center or may need ad hoc advisory group; information on agency

utilization, similar coverage decisions may need agency or other health plan input; information on current

practice in community or beneficiary preference may need further public input. Delegation should

include specific instructions on the task, assignment or issue; include a time frame; provide direction on

membership or input if a group is to be convened.

UEfficacy Considerations:

What is the evidence that use of the technology results in more beneficial, important

health outcomes? Consider: o Direct outcome or surrogate measure

o Short term or long term effect

o Magnitude of effect

o Impact on pain, functional restoration, quality of life

o Disease management

What is the evidence confirming that use of the technology results in a more beneficial outcome,

compared to no treatment or placebo treatment?

What is the evidence confirming that use of the technology results in a more beneficial outcome,

compared to alternative treatment?

What is the evidence of the magnitude of the benefit or the incremental value

Does the scientific evidence confirm that use of the technology can effectively replace other

technologies or is this additive?

For diagnostic tests, what is the evidence of a diagnostic tests’ accuracy

o Does the use of the technology more accurately identify both those with the condition

being evaluated and those without the condition being evaluated?

Does the use of the technology result in better sensitivity and better specificity?

Is there a tradeoff in sensitivity and specificity that on balance the diagnostic technology is

thought to be more accurate than current diagnostic testing?

Does use of the test change treatment choices

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USafety

What is the evidence of the effect of using the technology on significant morbidity?

o Frequent adverse effect on health, but unlikely to result in lasting harm or be life-

threatening, or;

o Adverse effect on health that can result in lasting harm or can be life-threatening.

Other morbidity concerns

Short term or direct complication versus long term complications

What is the evidence of using the technology on mortality – does it result in fewer

adverse non-fatal outcomes?

UCost Impact

Do the cost analyses show that use of the new technology will result in costs that are greater,

equivalent or lower than management without use of the technology?

UOverall

What is the evidence about alternatives and comparisons to the alternatives

Does scientific evidence confirm that use of the technology results in better health outcomes than

management without use of the technology?

Health Technology Assessment - HTA · 2017-06-16 · Health Technology Assessment - HTA Washington...

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Transcript of Health Technology Assessment - HTA · 2017-06-16 · Health Technology Assessment - HTA Washington...